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CTRI Number  CTRI/2022/10/046352 [Registered on: 11/10/2022] Trial Registered Prospectively
Last Modified On: 11/10/2022
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Other (Specify) [Edible Oil]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Efficacy of a Multisource Edible Oil on the improvement of heart health. 
Scientific Title of Study   An open label, multi centric, controlled observational clinical study to determine the efficacy of Multi Source Edible Oil (MSEO1) on outcomes in patients with cardiovascular disease. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR PARIKSHIT DEBNATH 
Designation  Consultant 
Affiliation  MED PHARMA CRO 
Address  119 Rajdanga Gold Park Kolkata - 700107

Kolkata
WEST BENGAL
700037
India 
Phone  9836675720  
Fax    
Email  docdebnath84@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR PARIKSHIT DEBNATH 
Designation  Consultant 
Affiliation  MED PHARMA CRO 
Address  119 Rajdanga Gold Park Kolkata - 700107

Kolkata
WEST BENGAL
700037
India 
Phone  9836675720  
Fax    
Email  docdebnath84@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR PARIKSHIT DEBNATH 
Designation  Consultant 
Affiliation  MED PHARMA CRO 
Address  119 Rajdanga Gold Park Kolkata - 700107

Kolkata
WEST BENGAL
700037
India 
Phone  9836675720  
Fax    
Email  docdebnath84@gmail.com  
 
Source of Monetary or Material Support  
Emami Agrotech Limited Emami Tower, 3rd Floor 687, Eastern Metropolitan Bypass, Anandapur, Kolkata - 700107 
 
Primary Sponsor  
Name  Med Pharma CRO 
Address  119 Rajdanga Gold Park, RB Connector, Kasba, Kolkata - 700107 
Type of Sponsor  Contract research organization 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Parikshit Debnath  Aktriana Ayurveda and Wellness  64/98B/1 Khudiram Bose Sarani Kolkata - 700037
Kolkata
WEST BENGAL 		 9836675720

docdebnath84@gmail.com 
Dr Parikshit Debnath  The Ayurveda Clinic and Research Centre  119 Rajdanga Gold Park Kolkata - 700107
Kolkata
WEST BENGAL 		 9836675720

docdebnath84@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Independent Ethics Committee (Clinical Research) India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E785||Hyperlipidemia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Emami Multisource Edible Oil (MSEO1) as cooking oil  dose- 30 ml per day frequency route of administration - edible cooking oil, to be taken internally duration of intervention - 28 days 
Comparator Agent  Himani Best Choice Sunflower Oil (MSEO2) as cooking oil  dose- 30 ml per day frequency route of administration - edible cooking oil, to be taken internally duration of intervention - 28 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Male and female subjects in the age group of 18 years and above.
2. Participants suffering under any one or more of the signs and symptoms like hypertension, dyslipidaemia.
3. Participants willing to give written informed consent.
4. Participants are fit and no need any hospital administration.
5. Willing to cook with the supplied oil and ability to adhere to dosing and visit schedules and meet study requirements.
6. Agree to following instruction of do’s and don’ts in regular daily lifestyle.
7. Study participants willing to perform all study related procedures allowing the physical and other invasive or non-invasive tests and willing to document symptoms and medication.
 
 
ExclusionCriteria 
Details  1. Study participants unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
2. Inability to carry out testing for the study.
3. Chronic & acute disorders requiring hospital admission.
4. Known HIV-positive, Hepatitis B or C status. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Improvement of Cholesterol
2.Improvement of Blood Pressure
3.Maintaining Cardiovascular Health
4.Improvement of GI issues

BMI, BP, CBC, Lipid profile, hsCRP, CPK, Vitamin K 		 BMI, BP, CBC, Lipid profile, hsCRP, CPK, Vitamin K

Baseline compared after 28 days
then crosover (washout phase 7 days) and again compared after 28 days 
 
Secondary Outcome  
Outcome  TimePoints 
No serious adverse events  28 days each group 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   13/10/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet. To be published in scientific journal after completion 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  tables, figures, text

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [medpharmacro@gmail.com].

  6. For how long will this data be available start date provided 01-04-2023 and end date provided 31-03-2024?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Open label multicentric post-marketing  study will be undertaken at Kolkata. Study design will be crossover and each group will consume the study oil (MSEO1) and control oil (MSEO2) for 28 days each with a washout phase of 7 days in between. A total of 60 study participants having dyslipidemia and/or hypertension will be equally distributed in 2 groups (study and control). Primary outcome are maintaing cardiovascular health, improvement in cholesterol and blood pressure levels. Secondary outcomes wlll be monioring adverse events. After screening participants giving written informed consent will be enrolled in respective groups. Then they will undergo physical assessment, assessment with study questionnaire and biochemical tests. Study oils will be provided to participants free of cost.  
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